recombine endostatin with neoadjuvant chemotherapy followed by concurrent chemoradiation in advanced nasopharynx cancer

Conditions: 1、Enough Cases; 2、Elekta Precise 1343 Digital Control Electron Linear Accelerator; Can Undertake Nasopharyngeal Carcinoma Specimens in the Materia，; Image Department of Nose Pharynx Ministry MRI Dynamic Testing,

Summary: 1) observe and compare the curative effect of endostatin/recombined endostatin in alliance with neoadjuvant chemotherapy and concurrent chemo-radio therapy to treat the local advanced nasopharyngeal darcinoma; 2) evaluate the security and tolerability in endostatin/recombined endostatin in alliance with neoadjuvant chemotherapy and concurrent chemo-radio therapy to treat the local advanced nasopharyngeal darcinoma.

1. experimental group:docetaxel 75mg/m2 iv in day 1 +cisplatin 80mg/m2 iv in day 1 +human endostatin 7.5mg/m2 iv in day 8-21 and three weeks repeat and total two cycles;followed by concurrent chemoradiation(cisplatin 80mg/m2 iv in day 1,21 +human endostatin 7.5mg/m2 iv in day 1-14 and concurrent intensity-modulated radiation therapy) 2. control group:group:docetaxel 75mg/m2 iv in day 1 +cisplatin 80mg/m2 iv in day 1 and three weeks repeat and total two cycles;followed by concurrent chemoradiation(cisplatin 80mg/m2 iv in day 1,21 and concurrent intensity-modulated radiation therapy)

Eligibility criteria:
inclusion criteria: 1. voluntary and sign the informed consent form; 2) age 18-70 years old, male or female; 3) histologically proved to be keratinizing carcinoma or non-keratinizing carcinoma; 4) nasopharyngeal darcinoma 2010 uicc staging iii-iv a, iv b; 5) measurable primary tumors; 6) karnofsky score≥70; ecog≥2; 7) expected survival≥6 months; 8) women in productive age should guarantee use contraceptives during study period; 9) hemoglobin(hgb) ≥100g/l, white blood cell(wbc) ≥4×109 /l，platelet（plt）≥100×109 /l.（or white blood cell and platelet not less than our hospital's normal lowest index）; 10) liver function: alanine amino transferase (alat), aspartate aminotransferase (asat) \<1.5 times the upper limit of the normal index; total bilirubin\<1.5×uln; 11) liver function: serum creatinine\<1.5×uln; 12) do not have severe complication, such as hypertensio, diabetes and history of mental illness; 13) this treatment is first treatment process (do not have a h\&n radiation history; do not have a history of concurrent chemoradiotherapy; do not have chemotherapy history in 3 months. exclusion criteria: 1. have a distant metastasis; 2) the primary focal tumors or lymph node already had a surgical treatment (except for biopsy); 3) already had a radiotherapy for primary focal or lymph node; 4) patient who received the the epidermal growth factor targeted therapy; 5) the primary focal had received chemoradiotherapy or immunotherapy; 6) patient who suffered from other malignant tumor (except for cured basal cell carcinoma or carcinoma in situ of cervix); 7) subject who have taken other drug test in 1 month; 8) peripheral neuropathy\> level; 9) pregnant woman or lactating women and women in productive age who refuse take contraception in observation period; 10) subject with a severe allergic history or idiosyncratic; 11) subject with severe pulmonary and cardiopathic disease history; 12) refuse or incapable to sign the informed consent form of participating this trial; 13) drug abuse or alcohol addicted; 14) subject with a personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct.

Keywords: nasopharynx cancer,image department of nose pharynx ministry